510(k) · Cleared
Cleared45 Micron Polyisoprene Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suretex Limited · MOL Condom, Synthetic
Cleared on Oct 27, 2023 as substantially equivalent to K160399 (Ansell Healthcare Products, LLC, 2016) after a 120-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Oct 27, 2023
- Review
- 120 days
- Class
- Class II
- Product code
- MOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941258 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK941258 Latex CondomSuretex, Ltd. · 1995 · Recalled
- 2 generations backK070800 Lifestyles Lubricated Polyisoprene Latex Male CondomAnsell Healthcare Products, LLC · 2008
- 1 generation backK160399 Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC · 2016 · Recalled
- This deviceK231908 45 Micron Polyisoprene CondomSuretex Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941258 | Latex Condom | Suretex, Ltd. | 1995 | 1 |
| −2 | K070800 | Lifestyles Lubricated Polyisoprene Latex Male Condom | Ansell Healthcare Products, LLC | 2008 | — |
| −1 | K160399 | Skyn Original Polyisoprene Lubricated Male Condom | Ansell Healthcare Products, LLC | 2016 | 1 |
| 0 (this device) | K231908 | 45 Micron Polyisoprene Condom | Suretex Limited | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOL device
- #1 K252158 Sagami Original 002 Polyurethane Male Condomscore 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160399 | Skyn Original Polyisoprene Lubricated Male CondomSummary page 4…s II 5. Predicate Device Information Device Name: SKYN Original Polyisoprene Lubricated Male Condom 510(k) Number: K160399 Sponsor: Ansell Healthcare Products, LLC The predicate device has not been subject to a design-r… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K160399.
How does its category compare?
All MOL devicesMOL Condom, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MOL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOL
244in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOL
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOL
4in 2025
MAUDE reports naming product code MOL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 2 | — | 0 | 9 |
| 2018 | 1 | — | 3 | 11 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 3 | 244 | 0 | 2 |
| 2025 | 2 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The 45 Micron Polyisoprene Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections STIs).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231908: 45 Micron Polyisoprene Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231908
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026